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  • ||||||||||  Tabex (cytisinicline) / Achieve Life Sciences
    Clinical, Journal:  Cytisinicline for Smoking Cessation: A Randomized Clinical Trial. (Pubmed Central) -  Jul 15, 2023   
    P3
    Both 6- and 12-week cytisinicline schedules, with behavioral support, demonstrated smoking cessation efficacy and excellent tolerability, offering new nicotine dependence treatment options. ClinicalTrials.gov Identifier: NCT04576949.
  • ||||||||||  Chantix (varenicline) / Pfizer, Tabex (cytisinicline) / Achieve Life Sciences
    Trial completion, Trial completion date, Trial primary completion date:  Varenicline Versus Cytisine for Smoking Cessation in Primary Care Setting (clinicaltrials.gov) -  Nov 3, 2022   
    P3,  N=352, Completed, 
    Recruiting --> Active, not recruiting Unknown status --> Completed | Trial completion date: Oct 2021 --> Nov 2022 | Trial primary completion date: Jul 2021 --> Sep 2022
  • ||||||||||  Tabex (cytisinicline) / Achieve Life Sciences
    Enrollment closed:  ORCA-3: A Second Study of Cytisinicline for Smoking Cessation in Adult Smokers (clinicaltrials.gov) -  Sep 28, 2022   
    P3,  N=750, Active, not recruiting, 
    The cytisinicline therapeutic dose being evaluated in Phase 3 clinical trials is 3 mg, which is a 10fold lower dose than the 30 mg MTD level for cytisinicline, resulting in an excellent safety margin. Recruiting --> Active, not recruiting
  • ||||||||||  apatorsen (OGX-427) / Achieve Life Sciences
    Journal:  DDX5 mRNA-targeting Antisense Oligonucleotide as a new promising therapeutic in combating Castration-Resistant Prostate Cancer. (Pubmed Central) -  Aug 17, 2022   
    The Heat Shock Protein 27 (Hsp27) has emerged as a principal factor of the Castration-Resistant Prostate Cancer (CRPC) progression, also, an Antisense Oligonucleotide (ASO) against Hsp27 (OGX-427 or Apatorsen) has been assessed in different clinical trials...We first present the interactions of DDX5 and the Ku70/80 heterodimer and the transcription factor IIH (TFIIH), thereby uncovering DDX5 roles in different DNA repair pathways. Collectively, our study highlights critical functions of DDX5 contributing to CRPC progression and provides preclinical proof-of-concept that a combination of ASO-directed DDX5 inhibition with a DNA damage-inducing therapy can serve as a highly potential novel strategy to treat CRPC.
  • ||||||||||  Tabex (cytisinicline) / Achieve Life Sciences
    Enrollment open:  ORCA-V1: A Study of Cytisinicline for Vaping Cessation in Adult Smokers (clinicaltrials.gov) -  Jul 4, 2022   
    P2,  N=150, Recruiting, 
    Collectively, our study highlights critical functions of DDX5 contributing to CRPC progression and provides preclinical proof-of-concept that a combination of ASO-directed DDX5 inhibition with a DNA damage-inducing therapy can serve as a highly potential novel strategy to treat CRPC. Not yet recruiting --> Recruiting
  • ||||||||||  Tabex (cytisinicline) / Achieve Life Sciences
    Clinical, P2b data, Journal:  A Multicenter, Double-blind, Randomized, Placebo-controlled Phase 2b Trial of Cytisinicline in Adult Smokers (The ORCA-1 Trial). (Pubmed Central) -  Nov 29, 2021   
    Although the 1.5mg 25-day titration schedule has been marketed in Central and Eastern Europe for decades, this study explored using a higher dosage and a simplified dosing schedule for impact on cytisinicline efficacy and tolerability. Based on these results, a Phase 3 program was initiated using cytisinicline 3 mg tablets on a TID schedule for potential market approval in the United States.
  • ||||||||||  custirsen (OGX-011) / Achieve Life Sciences
    Review, Journal:  The multiple roles and therapeutic potential of clusterin in non-small-cell lung cancer: a narrative review. (Pubmed Central) -  Jul 28, 2021   
    By silencing CLU using Custirsen (OGX-011), a second-generation antisense oligonucleotide (ASO) that inhibits CLU production, not only could sensitized cells to chemo- and radiotherapy, also could decreased their metastatic potential. We will review here the extensive literature linking CLU to NSCLC, update the current state of research on CLU for better understanding of this unique protein and the development of more effective anti- CLU treatment.
  • ||||||||||  custirsen (OGX-011) / Achieve Life Sciences
    Review, Journal:  Clusterin as modulator of carcinogenesis: A potential avenue for targeted cancer therapy. (Pubmed Central) -  Jul 21, 2021   
    In this review, we have discussed the detailed mechanism of CLU-mediated modulation of different cancer-associated signaling pathways. We have also provided updated information on the current preclinical and clinical findings that drive trials in various cancer types for potential targeted cancer therapy.
  • ||||||||||  Tabex (cytisinicline) / Achieve Life Sciences
    Journal:  Natural Alkaloid Compounds as Inhibitors for Alpha-Synuclein Seeded Fibril Formation and Toxicity. (Pubmed Central) -  Jul 17, 2021   
    Furthermore, using cell viability assays, six of these compounds inhibited α-syn-seeding-dependent toxicity. These six potent inhibitors of amyloid fibril formation and toxicity caused by the seeding process represent a promising therapeutic strategy for the treatment of PD and other synucleinopathies.
  • ||||||||||  Chantix (varenicline) / Pfizer, Tabex (cytisinicline) / Achieve Life Sciences
    Clinical, Journal:  Effect of Cytisine vs Varenicline on Smoking Cessation: A Randomized Clinical Trial. (Pubmed Central) -  Jul 15, 2021   
    Among daily smokers willing to quit, cytisine treatment for 25 days, compared with varenicline treatment for 84 days, failed to demonstrate noninferiority regarding smoking cessation. anzctr.org.au Identifier: ACTRN12616001654448.
  • ||||||||||  Tabex (cytisinicline) / Achieve Life Sciences
    Preclinical, Journal:  Cytisine Exerts an Anti-Epileptic Effect via α7nAChRs in a Rat Model of Temporal Lobe Epilepsy. (Pubmed Central) -  Jul 13, 2021   
    Conclusion and Implications: Taken together, these findings indicate that cytisine exerted an anti-epileptic and neuroprotective effect in TLE rats via activation of α7nAChRs, which was associated with a decrease in glutamate levels, inhibition of synaptic remodeling, and improvement of cholinergic transmission in the hippocampus. Hence, our findings not only suggest that cytisine represents a promising anti-epileptic drug, but provides evidence of α7nAChRs as a novel therapeutic target for TLE.
  • ||||||||||  Tabex (cytisinicline) / Achieve Life Sciences
    Enrollment closed:  ORCA-2: A Study of Cytisinicline for Smoking Cessation in Adult Smokers (clinicaltrials.gov) -  Jul 6, 2021   
    P3,  N=792, Active, not recruiting, 
    The findings have implications for rational design of subtype-selective nAChR agents. Recruiting --> Active, not recruiting
  • ||||||||||  Chantix (varenicline) / Pfizer, Tabex (cytisinicline) / Achieve Life Sciences
    [VIRTUAL] Promising New Tobacco Cessation Treatments () -  Jun 28, 2021 - Abstract #CPDD2021CPDD_675;    
    Among its conclusions, this report determined that existing FDA-approved treatments (NRT, bupropion, varenicline) are safe and efficacious but drastically underutilized, with various factors limiting their appeal, reach, and effectiveness...Cindy Jacobs (Achieve Life Sciences) will provide an overview of clinical research and Phase 3 development of Cytisinicline, a nicotinic acetylcholine receptor partial agonist, 3) Dr...Evan Herrmann and Kevin Walton (Division of Therapeutics and Medical Consequences, NIDA) will serve as symposium chair and co-chair, respectively. These scientifically diverse talks focus on new data spanning multiple Phases of development, providing researchers and clinicians with cutting-edge information on promising new smoking cessation treatments and broader insights into treatment development and regulatory processes.